CA2885196C - Compositions pharmaceutiques ayant une plus grande stabilite au stockage - Google Patents

Compositions pharmaceutiques ayant une plus grande stabilite au stockage Download PDF

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Publication number
CA2885196C
CA2885196C CA2885196A CA2885196A CA2885196C CA 2885196 C CA2885196 C CA 2885196C CA 2885196 A CA2885196 A CA 2885196A CA 2885196 A CA2885196 A CA 2885196A CA 2885196 C CA2885196 C CA 2885196C
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Prior art keywords
compound
weight percent
pharmaceutical composition
antipsychotic agent
months
Prior art date
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CA2885196A
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CA2885196A1 (fr
Inventor
Jason M. Perry
Daniel R. Deaver
Magali B. Hickey
Julius F. Remenar
Jennifer Vandiver
Michael J. Palmieri, Jr.
Zhengzheng Pan
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Alkermes Pharma Ireland Ltd
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Alkermes Pharma Ireland Ltd
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Publication of CA2885196A1 publication Critical patent/CA2885196A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/20—Oxygen atoms
    • C07D215/22—Oxygen atoms attached in position 2 or 4
    • C07D215/227—Oxygen atoms attached in position 2 or 4 only one oxygen atom which is attached in position 2

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne une composition pharmaceutique qui fournit une stabilité à long terme d'un agent antipsychotique hydrolytiquement labile.
CA2885196A 2012-09-19 2013-09-19 Compositions pharmaceutiques ayant une plus grande stabilite au stockage Active CA2885196C (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261702881P 2012-09-19 2012-09-19
US61/702,881 2012-09-19
US201361780862P 2013-03-13 2013-03-13
US61/780,862 2013-03-13
PCT/IB2013/002995 WO2014080285A2 (fr) 2012-09-19 2013-09-19 Compositions pharmaceutiques ayant une plus grande stabilité au stockage

Publications (2)

Publication Number Publication Date
CA2885196A1 CA2885196A1 (fr) 2013-09-19
CA2885196C true CA2885196C (fr) 2021-06-22

Family

ID=50339464

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2885196A Active CA2885196C (fr) 2012-09-19 2013-09-19 Compositions pharmaceutiques ayant une plus grande stabilite au stockage

Country Status (8)

Country Link
US (8) US9193685B2 (fr)
EP (2) EP3718536A1 (fr)
JP (2) JP6654042B2 (fr)
AU (1) AU2013349388B2 (fr)
CA (1) CA2885196C (fr)
ES (1) ES2792149T3 (fr)
NZ (3) NZ631345A (fr)
WO (1) WO2014080285A2 (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8431576B2 (en) 2009-06-25 2013-04-30 Alkermes Pharma Ireland Limited Heterocyclic compounds for the treatment of neurological and psychological disorders
LT2685979T (lt) 2011-03-18 2016-12-12 Alkermes Pharma Ireland Limited Injekcinės farmacinės kompozicijos, apimančios vandenyje netirpų antipsichotiką, sorbitano lauratą ir polisorbatą 20
WO2013142198A1 (fr) 2012-03-19 2013-09-26 Alkermes Pharma Ireland Limited Compositions pharmaceutiques comprenant des esters d'acides gras
ES2764383T3 (es) 2012-03-19 2020-06-03 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden ésteres de glicerol
CA2867137C (fr) 2012-03-19 2020-12-08 Alkermes Pharma Ireland Limited Compositions pharmaceutiques renfermant des promedicaments d'aripiprazole et d'alcool benzylique
NZ631345A (en) 2012-09-19 2017-06-30 Alkermes Pharma Ireland Ltd Pharmaceutical compositions having improved storage stability
BR112016021535A8 (pt) 2014-03-20 2021-07-20 Alkermes Pharma Ireland Ltd kit compreendendo formulações de aripiprazol tendo velocidades de injeção aumentadas útil para o tratamento de uma desordem do sistema nervoso central e uso
SMT201900236T1 (it) * 2014-08-18 2019-07-11 Alkermes Pharma Ireland Ltd Composizione per profarmaci di aripiprazolo
US10016415B2 (en) 2014-08-18 2018-07-10 Alkermes Pharma Ireland Limited Aripiprazole prodrug compositions
SI3185867T1 (sl) * 2014-08-25 2021-08-31 Alkermes Pharma Ireland Limited Postopek kristalizacije aripiprazolnih derivatov v formulacijah s podaljšanim sproščanjem za zdravljenje shizofrenije
US10815216B2 (en) 2016-12-14 2020-10-27 Neuland Pharma Research Private Limited Process for the preparation of aripiprazole lauroxil
US20180265472A1 (en) * 2017-03-17 2018-09-20 Scinopharm Taiwan, Ltd. Process for preparing aripiprazole lauroxil and intermediates thereof
CN111315722B (zh) * 2017-07-28 2023-06-16 因特奎姆私人控股公司 制备月桂酰阿立哌唑的方法
CA3092335A1 (fr) 2018-03-05 2019-09-12 Alkermes Pharma Ireland Limited Strategie de dosage d'aripiprazole
CN110790703A (zh) * 2018-08-01 2020-02-14 北京万全德众医药生物技术有限公司 月桂酰阿立哌唑的制备方法

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US20200268891A1 (en) 2020-08-27
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US11097006B2 (en) 2021-08-24
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US20220072133A1 (en) 2022-03-10
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US12311027B2 (en) 2025-05-27
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